MedTrace Logo

The Effect of a Probiotic Strain on Aspirin-induced GI Damage.

NCT03228589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2018-05-03

No results posted yet for this study

Summary

This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.

Conditions

  • Side Effects of Acetylsalicylic Acid Use

Interventions

DIETARY_SUPPLEMENT

probiotic strain

8 weeks of treatment with probiotic strain

DIETARY_SUPPLEMENT

Placebo

8 weeks of treatment

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Chr Hansen

    lead INDUSTRY

Principal Investigators

  • Martin Buckley, Dr · GI Physiology Laboratory, Mercy University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-15
Primary Completion
2017-12-21
Completion
2018-04-04

Countries

  • Ireland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228589 on ClinicalTrials.gov